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Trial record 19 of 34 for:    myopic macular degeneration

Cohort Study of the Clinical Course of Macular Diseases in Kagawa

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ClinicalTrials.gov Identifier: NCT02321267
Recruitment Status : Recruiting
First Posted : December 22, 2014
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Akitaka Tsujikawa, Kagawa University

Brief Summary:

Macular diseases often cases severe visual impairment. Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of various macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic macular edema (DME), and so forth. The advance in vitrectomy improve visual outcomes in some maculae diseases, including epiretinal membrane (ERM), macular hole (MH), vitreomacular traction syndrome (VMTS).

Patients with such macular diseases are registered and are followed up for 5 years with appropriate treatment for each patient. By the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.


Condition or disease Intervention/treatment Phase
Macular Disease Drug: ranibizumab, aflibercept, pegaptanib, verteporphin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cohort Study of the Clinical Course of Macular Diseases in Kagawa (Kagawa Macula Cohort Study)
Study Start Date : December 2014
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Macular disease with adequate treatments
Macular diseases can be treated with most appropriate treatment, including pegaptanib, ranibizumab, afibercept, visudyne, or vitrectomy.
Drug: ranibizumab, aflibercept, pegaptanib, verteporphin
ranibizumab, intravitreal injections, 0.5mg, monthly or less aflibercept,intravitreal injections, 2.0mg, monthly or less pegaptanib, intravitreal injections, 0.3mg, every 6-week pars plana vitrectomy, once verteporphin, iv, 6mg/㎡
Other Name: Lucentis, Eylea, Macugen, Vizudyne




Primary Outcome Measures :
  1. Change of best-collected visual acuity from baseline at 5 years [ Time Frame: Five years after the registration ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who visit Department of Ophthalmology, Kagawa University Hospital with macular diseases, such as AMD, PCV, RAP, RVO, DME, ERM, MH, VMTS.
  • Patients who are agreed with the participation of this study.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321267


Contacts
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Contact: Chika Akuta +81-87-891-2211 kaomie@med.kagawa-u.ac.jp

Locations
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Japan
Kagawa University Faculty of Medicine Recruiting
Miki, Kagawa, Japan, 761-0793
Contact    +81878912211    chosa@med.kagawa-u.ac.jp   
Sponsors and Collaborators
Kagawa University
Investigators
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Principal Investigator: Akiataka Tsujikawa, MD Kagawa Univerisity Faculty of Medicine

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Responsible Party: Akitaka Tsujikawa, Professor and Chairman, Kagawa University
ClinicalTrials.gov Identifier: NCT02321267     History of Changes
Other Study ID Numbers: H26-035
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Keywords provided by Akitaka Tsujikawa, Kagawa University:
AMD
PCV
RAP
RVO
DME
ERM
MH
mCNV

Additional relevant MeSH terms:
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Ranibizumab
Verteporfin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents